Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy With or Without Fluorouracil and/or Pegfilgrastim in Treating Women With Node-Positive Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed 18 to 70 Other GIM-2 EU-20681, NCT00433420

Objectives

Primary

1. Compare the efficacy of adjuvant therapy comprising epirubicin hydrochloride, cyclophosphamide, and paclitaxel with vs without fluorouracil and/or pegfilgrastim in women with node-positive breast cancer.

Secondary

1. Compare the overall survival of patients treated with these regimens.
2. Compare the safety of these regimens in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed primary breast cancer
  • No histology other than carcinoma



• Node-positive disease
  • Must have at least 1 involved axillary node or internal mammary node



• Previously resected disease
  • Has undergone radical surgery (i.e., mastectomy or conservative surgery) with axillary node dissection within the past 7 weeks



• No inflammatory carcinoma



• No prior or concurrent ipsilateral or contralateral invasive breast carcinoma



• No metastatic disease, including metastasis in the ipsilateral supraclavicular lymph nodes



• Hormone receptor status not specified

Prior/Concurrent Therapy:

• See Disease Characteristics
• No prior chemotherapy
• No prior cytotoxic regimens
• No prior radiation therapy, except for intraoperative radiation therapy

Patient Characteristics:

• Female
• Menopausal status not specified
• ECOG performance status 0-1
• Absolute neutrophil count ≥ 1,500/mm³
• WBC ≥ 4,000/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9 g/dL
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• Creatinine ≤ 1.5 times ULN
• AST and ALT ≤ 2.5 times ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No chronic liver or renal disease
• No other serious medical illness requiring medication
• No other malignancy except adequately treated, cone-biopsied in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin
• No symptomatic peripheral neuropathy > grade 2
• No hypersensitivity to study drugs or their components
• No recent myocardial infarction, congestive heart failure, or serious arrhythmia

Expected Enrollment

A total of 2,000 patients will be accrued for this study.

Outcomes

Disease-free survival

Overall survival
Toxicity

Outline

This is a randomized, multicenter study. Patients are randomized to 1 of 4 treatment arms.

• Arm I: Patients receive epirubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 3 weeks for 4 courses. Patients then receive paclitaxel IV over 3 hours on day 1. Treatment with paclitaxel repeats every 3 weeks for 4 courses.



• Arm II: Patients receive fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 3 weeks for 4 courses. Patients then receive paclitaxel as in arm I.



• Arm III: Patients receive epirubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 4. Treatment repeats every 2 weeks for 4 courses. Patients then receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim subcutaneously (SC) on day 4. Treatment with paclitaxel and pegfilgrastim repeats every 2 weeks for 4 courses.



• Arm IV: Patients receive fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 4. Treatment repeats every 2 weeks for 4 courses. Patients then receive paclitaxel and pegfilgrastim as in arm III.

In all arms, treatment continues in the absence of disease progression or unacceptable toxicity. After completion of chemotherapy with or without pegfilgrastim, patients may undergo external-beam radiation therapy at the discretion of treating center. Patients with positive estrogen and/or progesterone receptor tumor receive tamoxifen for 5 years.

After completion of study treatment, patients are followed periodically for 5 years and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

Gruppo Italiano Mammella

Marco Venturini, MD, Protocol chair		Ph: 39-045-601-3912

Registry Information
Official Title		A Phase III Randomized Study of EC Followed by Paclitaxel Versus FEC Followed by Paclitaxel, All Given Either Every 3 Weeks or 2 Weeks Supported by Pegfilgrastim, for Node Positive Breast Cancer Patients
Trial Start Date		2003-04-24
Registered in ClinicalTrials.gov		NCT00433420
Date Submitted to PDQ		2006-12-18
Information Last Verified		2007-05-07